OBJECTIVE: To test the hypothesis that prophylactic treatment of neutropenic premature neonates withrecombinant granulocyte-colony stimulating factor (rG-CSF) would reduce the incidence of nosocomial infections (NIs). STUDY DESIGN: A total of 25 neonatal intensive care units participated in this multicenter, randomized, double-blind, placebo-controlled trial. Premature infants of gestational age (GA) <or= 32 weeks were included if they had a peripheral blood count showing < 1500 neutrophils/mm(3) for at least 24 hours during the first 3 weeks of life. A total of 200 infants received eitherrG-CSF (10 microg/kg/day) or placebo for 3 days. Primary outcome was survival free of infection for 4 weeks after treatment, assessed in an intention-to-treat analysis. RESULTS: A total of 102 infants receivedrG-CSF (mean GA, 29.2 weeks), and 98 received placebo (mean GA, 29.1 weeks). Survival free of confirmed infection for 4 weeks after treatment was 74/102 in the rG-CSF group and 66/98 in the placebo group (P = .42). However, during 2 weeks, there was a significant difference between groups (86/102 vs 70/98; P = .028). CONCLUSIONS: In this population, prophylactic rG-CSF did not significantly increase survival free of infection at 4 weeks after treatment. The transient effect observed at 2 weeks in the most immature infants should be evaluated further.
RCT Entities:
OBJECTIVE: To test the hypothesis that prophylactic treatment of neutropenic premature neonates with recombinant granulocyte-colony stimulating factor (rG-CSF) would reduce the incidence of nosocomial infections (NIs). STUDY DESIGN: A total of 25 neonatal intensive care units participated in this multicenter, randomized, double-blind, placebo-controlled trial. Premature infants of gestational age (GA) <or= 32 weeks were included if they had a peripheral blood count showing < 1500 neutrophils/mm(3) for at least 24 hours during the first 3 weeks of life. A total of 200 infants received either rG-CSF (10 microg/kg/day) or placebo for 3 days. Primary outcome was survival free of infection for 4 weeks after treatment, assessed in an intention-to-treat analysis. RESULTS: A total of 102 infants received rG-CSF (mean GA, 29.2 weeks), and 98 received placebo (mean GA, 29.1 weeks). Survival free of confirmed infection for 4 weeks after treatment was 74/102 in the rG-CSF group and 66/98 in the placebo group (P = .42). However, during 2 weeks, there was a significant difference between groups (86/102 vs 70/98; P = .028). CONCLUSIONS: In this population, prophylactic rG-CSF did not significantly increase survival free of infection at 4 weeks after treatment. The transient effect observed at 2 weeks in the most immature infants should be evaluated further.
Authors: James L Wynn; Hector R Wong; Thomas P Shanley; Matthew J Bizzarro; Lisa Saiman; Richard A Polin Journal: Pediatr Crit Care Med Date: 2014-07 Impact factor: 3.624
Authors: Tinnakorn Chaiworapongsa; Roberto Romero; Stanley M Berry; Sonia S Hassan; Bo Hyun Yoon; Samuel Edwin; Moshe Mazor Journal: J Perinat Med Date: 2011-07-30 Impact factor: 1.901
Authors: Jin A Lee; Brooke Sauer; William Tuminski; Jiyu Cheong; John Fitz-Henley; Megan Mayers; Chidera Ezuma-Igwe; Christopher Arnold; Christoph P Hornik; Reese H Clark; Daniel K Benjamin; P Brian Smith; Jessica E Ericson Journal: Am J Perinatol Date: 2016-09-20 Impact factor: 3.079